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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00238264




Registration number
NCT00238264
Ethics application status
Date submitted
12/10/2005
Date registered
13/10/2005
Date last updated
7/08/2019

Titles & IDs
Public title
Radiation Therapy in Treating Young Patients With Gliomas
Scientific title
A Phase II Study of Conformal Radiotherapy In Patients With Low-Grade Gliomas
Secondary ID [1] 0 0
COG-ACNS0221
Secondary ID [2] 0 0
ACNS0221
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Tumor 0 0
Central Nervous System Tumor 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Children's - Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - radiation therapy

Experimental: Treatment (radiotherapy) - Patients undergo reduced-field conformal radiation therapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.


Treatment: Other: radiation therapy
Undergo 3D-CRT Undergo proton radiation therapy Undergo IMRT
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Marginal-failure Rate
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Progression-free Survival Probability
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Event-free Survival Probability
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Overall Survival Probability
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
Quality of Life (QOL)
Timepoint [4] 0 0
Up to 5 years
Secondary outcome [5] 0 0
MIB-1 Labeling Index Using Immunohistochemical Techniques With the MIB-1 Antibody According to Established Methods
Timepoint [5] 0 0
At baseline
Secondary outcome [6] 0 0
Correlation MIB-1 Labeling Index With PFS
Timepoint [6] 0 0
Up to 10 years

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed* low-grade glioma, including any of the following:

- Juvenile pilocytic astrocytoma (JPA) or pleomorphic JPA

- Diffuse astrocytoma, including any of the following subtypes:

- Fibrillary astrocytoma

- Gemistocytic astrocytoma

- Subependymal giant cell astrocytoma

- Pleomorphic xanthoastrocytoma

- Low-grade oligoastrocytoma

- Low-grade oligodendroglioma

- Low-grade glioma not otherwise specified NOTE: *Patients with chiasmatic lesions
who have contiguous extension of tumor into other regions of the visual pathway
by CT scan or MRI are eligible without histopathologic confirmation; repeat
biopsy required for patients with recurrent tumors that enhance but whose initial
tumor did not

- Measurable disease by radiography

- Meets any of the following criteria:

- Progressive nonresectable disease

- Any location in the brain

- Patients with a less than gross total resection are eligible provided they are
symptomatic from their tumor OR the risk from neurologic impairment with
progression is high enough to warrant immediate treatment

- Has undergone biopsy only

- Must have received = 1 course of prior chemotherapy (for patients < 10 years of age)

- Prior chemotherapy optional (for patients = 10 years of age)

- No type-1 neurofibromatosis

- No evidence of leptomeningeal dissemination

PATIENT CHARACTERISTICS:

Age

- 3 to 20

Performance status

- ECOG 0-2 OR

- Karnofsky 50-100% (for patients > 16 years of age) OR

- Lansky 50-100% (for patients = 16 years of age)

Life expectancy

- At least 1 year

Hematopoietic

- Absolute neutrophil count = 1,000/mm^3

- Platelet count = 100,000/mm^3 (transfusion independent)

- Hemoglobin = 10.0 g/dL (transfusions allowed)

Hepatic

- Not specified

Renal

- Not specified

Other

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- Not in status epilepticus, coma, or requiring assisted ventilation prior to study
entry

- Patients with a seizure disorder are eligible provided they are on anticonvulsants AND
disease is well controlled

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

- Recovered from prior chemotherapy

- No concurrent chemotherapy

Endocrine therapy

- Concurrent dexamethasone allowed provided patient has been on a stable dose for = 2
weeks prior to study entry

- Concurrent dexamethasone allowed for symptoms of increased intracranial pressure

Radiotherapy

- No prior radiotherapy

Surgery

- See Disease Characteristics

Other

- No other concurrent anticancer therapy
Minimum age
3 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2018
Sample size
Target
Accrual to date
Final
92
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 0 0
Royal Children's Hospital - Brisbane
Recruitment hospital [2] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment postcode(s) [2] 0 0
6001 - Perth
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Delaware
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District of Columbia
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Florida
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Georgia
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Hawaii
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Idaho
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Illinois
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Indiana
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Iowa
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Kentucky
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Louisiana
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Michigan
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Mississippi
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Missouri
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Vermont
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Washington
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West Virginia
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Wisconsin
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British Columbia
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Auckland
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Christchurch
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Wellington
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Puerto Rico
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Santurce
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Switzerland
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Geneva
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Switzerland
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Lausanne

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Specialized radiation therapy that delivers radiation directly to the tumor may
kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase II trial is studying how well radiation therapy works in treating young
patients with gliomas.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00238264
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joel M. Cherlow, MD
Address 0 0
Todd Cancer Institute at Long Beach Memorial Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00238264